Dienosis Special Precautions

The patient must not use hormonal contraceptives of any form (tablet, patch, intrauterine system) while taking Dienosis.
Dienosis is NOT a contraceptive. If the patient wants to prevent pregnancy, the patient should use condoms or other non-hormonal contraceptive precautions.
In some situations, the patient needs to take special care while using Dienosis, and the doctor may need to examine the patient regularly. Tell the doctor if any of the following conditions applies to the patient: If the patient: has ever had a blood clot (venous thromboembolism) or anyone in the patient's immediate family has had a blood clot at a relatively early age.
Has a close relative who has had breast cancer.
Has ever suffered from depression.
Has high blood pressure or develop high blood pressure while taking Dienosis.
Develop a liver disease while taking Dienosis. Symptoms may include yellowing of the skin or eyes or itching all over the body. Inform the doctor also if such symptoms occurred during a previous pregnancy.
Has diabetes or had diabetes temporarily during previous pregnancy.
Has ever had chloasma (golden-brown patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation.
Suffer from pain in the lower abdomen while taking Dienosis.
While taking Dienosis, the chance of becoming pregnant is reduced because Dienogest may affect ovulation.
If the patient becomes pregnant while taking Dienosis, the patient is at a slightly increased risk of having an extrauterine pregnancy (the embryo develops outside the womb). Tell the doctor before the patient starts taking Dienosis, if the patient had an extrauterine pregnancy in the past or have an impaired function of the Fallopian tubes.
Dienosis and serious uterine bleeding: Uterine bleeding, for example in women with a condition where the mucous membrane of the uterus (endometrium) grows into the muscle layer of the uterus, called adenomyosis uteri or benign tumours of the womb sometimes called uterine fibroids (uterine leiomyomata), may become worse with the use of Dienosis. If bleeding is heavy and continuous over time, this may lead to low red blood cell levels (anemia), which may be severe in some cases. In the event of anemia, the patient should discuss with the doctor if the patient should stop taking Dienosis.
Dienosis and changes in bleeding pattern: Most women treated with Dienogest experience changes in their menstrual bleeding pattern (see Side Effects).
Dienogest and venous blood clots: Some studies indicate that there may be a slight, but not statistically significant, increased risk of a blood clot in the legs (venous thromboembolism) associated with the use of preparations with progestagens like Dienogest. Very rarely, blood clots may cause serious permanent disabilities or may even be fatal.
The risk of a venous blood clot increases: with increasing age; if the patient is overweight; if the patient or one of the patient's close relatives had a blood clot in the leg (thrombosis), lung (pulmonary embolism), or other organ at a young age; if the patient must have surgery, if the patient has had a serious accident or if the patient is immobilized for a long time. It is important to tell the doctor in advance that the patient is using Dienosis as the treatment may have to be stopped. The doctor will tell the patient when to start Dienosis again. This is usually about two weeks after the patient is back on the patient's feet.
Dienosis and arterial blood clots: There is little evidence for an association between preparations with progestagens like Dienogest and an increased risk of a blood clot in, for example, the blood vessels of the heart (heart attack) or the brain (stroke). In women with hypertension the risk of stroke may be slightly enhanced by these preparations.
The risk of an arterial blood clot increases: if the patient smokes. The patient is strongly advised to stop smoking when using Dienosis, especially if the patient is older than 35 years; if the patient is overweight; if one of the patient's close relatives had a heart attack or stroke at a young age; if the patient has high blood pressure.
Talk to the doctor before taking Dienosis.
Dienosis and cancer: It is not clear from the data currently available whether or not Dienosis increases the risk of breast cancer. Breast cancer has been observed slightly more often in women taking hormones compared to those not taking hormones, but it is not known whether this is caused by the treatment. For example, it may be that more tumours are detected and detected earlier in women taking hormones because they are examined by the doctor more often. The occurrence of breast tumours becomes gradually less after stopping the hormone treatment. It is important to regularly check the breasts and contact the doctor if the patient feels any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in women taking hormones. Contact the doctor if the patient has unusually severe stomach pain.
Dienosis and osteoporosis: Changes in bone mineral density (BMD): The use of Dienosis may affect the strength of the bone of adolescents (12 to under 18 years). If the patient is under 18, the doctor will, therefore, carefully weigh the benefits and risks of using Dienosis for, taking into account possible risk factors for bone loss (osteoporosis).
If the patient uses Dienosis, it will help the patient's bones if the patient has an adequate intake of calcium and vitamin D either via food or via supplements.
If the patient has an increased risk of getting osteoporosis (weakening of bones due to loss of bone minerals), the doctor will carefully weigh the risks and benefits of treatment with Dienosis because Dienosis has a moderate suppressing effect on the production of oestrogen (another type of female hormone) by the body.
Driving and using machines: No effects on the ability to drive and use machines have been observed in users of Dienogest.
Dienosis contains lactose: If the patient has been told by the doctor that the patient intolerance to some sugars, contact the doctor before taking this medicinal product.
Use in Children: Dienosis is not for use in girls before menarche (first menstrual bleeding).
The use of Dienosis may affect the strength of the bone of adolescents (12 to under 18 years). If the patient is under 18, the doctor will, therefore, carefully weigh the benefits and risks of using Dienosis for her as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).